Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors

This is a single-arm, unicentric, single-stage, phase 2 clinical study of therapeutic metaiodobenzylguanidine (MIBG) for patients with metastatic well-differentiated neuroendocrine tumors and radiological progression or intolerance after standard lines of treatment and with MIBG positive scan.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Age greater than or equal to 18 years
* Histological diagnosis of well-differentiated neuroendocrine tumor (NET) (typical and atypical lung carcinoids and NET of all gastroenteropancreatic sites according to World Health Organization (WHO) 2019 classification); metastatic/unresectable, with no possibility of curative treatment.
* MIBG-I131 positive scan in at least one lesion with uptake compatible with therapeutic effectiveness.
* Disease with radiological progression (at least 10 percent tumor volume growth) in the last 12 months before day 1 cycle 1.
* Intolerance due to toxicities or lack of access to standard treatments - \[private context (somatostatin analog, everolimus) and public health system (somatostatin analog)\].
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance scale 0 to 2.
* Adequate organic function as defined by the following criteria:

  * serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal of the local laboratory (ULN-LL);
  * Total serum bilirubin ≤ 2.0 x ULN-LL;
  * Absolute neutrophil count ≥ 1,500 / mm\^3;
  * Platelet count ≥ 100,000 / mm\^3;
  * Hemoglobin ≥ 9.0 g / dL;
  * Estimated creatinine clearance by the Modification of Diet in Renal Disease (MDRD) equation ≥ 60ml / min
* Term of free and informed consent signed by the patient or legal representative.

Exclusion Criteria:

* Patients already treated with MIBG-I131.
* A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study.
* Patients participating in other protocols with experimental drugs.
* Patients who underwent major recent surgery less than 4 weeks previously.
* Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks.
* Pregnant or lactating patients.
* Another synchronous neoplasm that requires systemic treatment.

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